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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

· 3h · on MSN

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

· 7h · on MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

· 7h

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

· 1d

Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting

· 6h

Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

Patient dies in Sarepta gene therapy trial, adding to safety concerns

The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the company’s transparency.

STAT1h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.

1hon MSN

Gene-therapy company to eliminate 21 Durham employees as part of major restructuring

Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.

12h

Friday's movers: Sarepta, Norfolk Southern, Netflix and more

These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg reported,

13h

Sarepta shares tumble after report of patient death in early-stage trial

Sarepta Therapeutics shares plunged premarket on Friday after the company disclosed another patient death linked to its gene therapy programs, this time during an early-stage trial for limb-girdle muscular dystrophy,